Data-driven, large-scale personalized epigenetic health analyses for early and individualized risk assessment in healthcare
| Reference number | |
| Coordinator | PredictMe AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | October 2025 - October 2026 |
| Status | Ongoing |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Competence Enhancement in Small Businesses 2025 |
Purpose and goal
The project aims to meet the ISO-13485 standard for “software as a medical device” and clinically validate PredictMe’s AI method for epigenetic analysis. The goal is for this work to form the basis for our creation of a CE-marked, cost-effective tool for early risk assessment of biological age and a number of other newly developed health markers in healthcare, especially at 50-year check-ups.
Expected effects and result
The project is expected to lead to work that enables a validated and CE-ready AI solution that improves disease risk assessment and treatment strategies. The result strengthens Swedish expertise in medical AI and epigenetics, increases healthcare efficiency, and positions PredictMe as a leader in XAI-based health technology.
Planned approach and implementation
The project is being implemented in three phases: (1) establishment of a quality system according to ISO-13485 in collaboration with regulatory expertise, (2) technical validation and optimization of the AI model against clinical data, and (3) preparation of documentation and processes for CE marking of the software as a medical device.